SYNAP-I INFANT SENSORY ASSESSMENT UNIT
Device Facts
| Record ID | K810138 |
|---|---|
| Device Name | SYNAP-I INFANT SENSORY ASSESSMENT UNIT |
| Applicant | Infant Hearing Assessment Foundation |
| Product Code | GWJ · Neurology |
| Decision Date | Apr 3, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.
